To the attention of interested persons
In October, Zentiva, Marketing Authorisation Holder of Digoxin Zentiva 0.25 mg, tablets, in Romania, notified the National Agency for Medicines and Medical Devices (NAMMD) on temporary discontinuation of marketing of the product, because of manufacturing-related issues.
Consequently, to meet the required amount of tablets (0.25 mg digoxin) for the upcoming period, the Ministry of Health and SC Unifarm SA have identified a different manufacturer. In this respect, upon request by SC Unifarm SA, the NAMMD has issued an authorisation for resolution of special needs, in line with regulations approved through Order of the Minister of Health no. 85/2013.